BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 4170041 · Received October 14, 2014

    Report

    Report Number
    1823260-2014-07851
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 12, 2014
    Report Date
    July 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K101299
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. MEDWATCH WITH (B)(6) IS COMPACT PLUS SYSTEM 1, MEDWATCH WITH (B)(6) IS COMPACT PLUS SYSTEM 2.

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 70 MG/DL ON AVIVA SYSTEM 1, 135 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES. CUSTOMER SELF-TREATED WITH 2 OUNCES OF DEX4 (LIQUID GLUCOSE). NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651329 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male ASPIRIN| CELLCEPT| DEX4| HUMALOG| PREDNISONE| PROGRAF| ASPIRIN| PROGRAF| PREDNISONE| CELLCEPT| DEX4| HUMALOG